USP CLASS PLASTICS (USP CLASS VI)

USP Class Plastic Tests are designed to assess the biological reactivity of various types of plastics materials in vivo. Originally developed to test drug containers, the class plastics tests are often performed on unmolded plastic resins as well as containers. Class plastics testing is not a substitute for biocompatibility testing, but is often used by manufacturers to classify materials.

The USP defines six plastics classes, from I to VI (VI being the most strict). Therefore, many plastics manufacturers find it advantageous to have their plastic resins certified as USP Class VI, especially if the resin is a likely candidate to be used in medical devices. A plastic resin material that has passed Class VI certification is assumed to be more likely to produce favorable biocompatibility results.

There are three in vivo tests involved in the classification of plastics. The Systemic Injection Test and the Intracutaneous Test are designed to determine the systemic and local biological responses to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample. The third test, the Implantation Test, is designed to evaluate the reaction of living tissue to a test material. The testing for the six different class plastics levels is all done using different combinations of these three tests and different extracts.

USP Class Plastics Testing ServiesUSP Class I-VI, consisting of:

USP Systemic Injection Test

USP Intracutaneuous Test

USP Implantation Test

PBL is FDA registered and ISO 9001:2008 and ISO 13485:2003 certified by Intertek.